BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000094-2012-02615

    MDR report key: 2865165 · Received December 10, 2012

    Report

    Report Number
    6000094-2012-02615
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE TREND DATA SHOWED AN ERROR CODE. IT WAS DETERMINED THAT THERE HAD BEEN A DEVICE RESET CAUSED BY A FLIPPED BIT IN THE MEMORY OF THE DEVICE. THE DEVICE RESET ITSELF AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVZ MEDTRONIC S.A. (SMO) C20A2U

    Patients

    Seq Age Sex Outcome Treatment
    1